Clinical Trial Corticoids For Empyema And Pleural Effusion In Children

Empyema Clinical Trial

— CORTEEC  

Official title:

MULTICENTRIC, PHASE II, CLINICAL TRIAL CORTICOIDS FOR EMPYEMA AND PLEURAL EFFUSION IN CHILDREN

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01261546
• Other study ID #: Hospital Infanta Sofia
• Secondary ID: 2009-012963-33
• Status: Completed
• Phase: Phase 2
• First received: December 15, 2010
• Last updated: May 29, 2015
• Start date: December 2010
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Hospital Infanta Sofia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

STUDY JUSTIFICATION

1. Scientific evidence of the usefulness of corticosteroid use for infectious diseases:

Corticosteroids along with antibiotic use improve survival in some infectious processes provide long term benefits and improve symptoms in many others.

2. Clinical Observation: the investigators observed that patients with parapneumonic pleural effusion and associated bronchospasm who were treated with corticosteroids for their bronchospasm, evolved to healing before patients who were not treated with corticosteroids (average admission days 10 vs. 17).

3. Rationale: the anti-inflammatory effect has been the rationale for the use of dexamethasone as an inhibitor of the inflammatory response observed after the first dose of parenteral antibiotic in bacterial meningitis. A similar effect is likely to occur in pneumonia with pleural effusion. It can be therefore hypothesized that Dexamethasone could inhibit an excessive inflammatory response by mesothelial and inflammatory cells during the early phases of parapneumonic empyema, reducing its severity and hence its complications.

OBJECTIVES

1. Principal: to investigate if dexamethasone 0,25mg/kg q.i.d. added to standard antibiotic therapy reduces time to resolution of parapneumonic pleural effusion.

2. Secondary:

2.1. Evaluate the effect of dexamethasone 0,25mg/kg q.i.d. added to standard antibiotic therapy on the development of complications during pleural effusion episode.

2.2. Evaluate the incidence of severe and non severe adverse events associated with the new treatment versus standard therapy.

METHODS

1. Study design: exploratory (pilot), randomized, double blinded, placebo controlled, parallel stratified design, multicentric.

2. Participating Hospitals (n=56, 7 patients per center):

• Hospital Infanta Sofía (S. Sebastián de los Reyes, Madrid).

• Hospital Universitario de Getafe

• Hospital Universitario Ramón y Cajal, Madrid.

• Hospital Universitario Materno-Infantil Carlos Haya, Málaga.

• Hospital Infantil La Paz, Madrid.

• Hospital U. Gregorio Marañón

• Hospital U. Príncipe de Asturias

• Hospital Virgen de la Salud, Toledo

3. Endpoints:

3.1. Primary: time to resolution. 3.2. Secondary endpoints:

1. Effectiveness: number of children with complications.

2. Safety (expected number: none). i) Hyperglycemia ii) Signs of gastrointestinal bleeding iii) Need of transfusion iv) Oropharyngeal Candidiasis v) Allergic reaction vi) Other adverse reactions described in the Medication Guide.

4. Treatment arms:

3.1. Control (0)

• Normal saline 0,6 ml/kg, IV, q.i.d. for 2 days.

• Cefotaxime 150 mg/kg, IV, q.d. until discharge criteria are present.

• Ranitidine 5 mg/kg IV, q.d. for 2 days.

• Amoxicillin- Clavulanic acid 80mg/kg p.o., q.d. during 15 days.

3.2. Study treatment: (1)

• dexamethasone 0,25mg/kg, IV, q.i.d. for 2 days.

• Cefotaxime 150 mg/kg, IV, q.d. until discharge criteria are present

• Ranitidine 5 mg/kg IV, q.d. for 2 days

• Amoxicillin/Clavulanic acid orally (80mg/kg/day) during 15 days.

4. INCLUSION CRITERIA

• Patients between 1 and 14 year old.

• Presence of pneumonia diagnosed by clinical and radiographic criteria: cough, fever and radiological consolidation.

• Evidence of pleural effusion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 14 Years

Eligibility

Inclusion Criteria:

• Patients between 1 and 14 year old.

• Presence of pneumonia diagnosed by clinical and radiographic criteria: cough, fever and radiological consolidation.

• Evidence of pleural effusion.

Exclusion Criteria:

• Allergy to any of the drugs included in the study.

• Immunodeficiency.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Empyema
• Parapneumonic Pleural Effusion
• Pleural Effusion

Intervention

Drug:
• Dexamethasone
Dexamethasone 0,25mg/kg, IV, q.i.d. for 2 days. Cefotaxime 200 mg/kg, IV, q.d. until discharge criteria are present Ranitidine 5 mg/kg IV, q.d. for 2 days Amoxicillin/Clavulanic acid orally (80mg/kg/day) during 15 days.
• Placebo
Normal saline 0,6 ml/kg, IV, q.i.d. for 2 days. Cefotaxime 200 mg/kg, IV, q.d. until discharge criteria are present. Ranitidine 5 mg/kg IV, q.d. for 2 days. Amoxicillin- Clavulanic acid 80mg/kg p.o., q.d. during 15 days.

Locations

Country	Name	City	State
Spain	Hospital Principe de Asturias	Alcalá de Henares	Madrid
Spain	Hospital Universitario de Getafe	Getafe	Madrid
Spain	Hospital Infantil La Paz	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Universitario Gregorio Marañón	Madrid
Spain	Hospital Carlos Haya	Malaga	Andalucia
Spain	Hospital Infanta Sofia	San Sebastián de los Reyes	Madrid
Spain	Complejo Hospitalario Toledo	Toledo	Castilla La Mancha

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Infanta Sofia	Pediatrics Spanish Association (Madrid and Castilla-La Mancha Pediatric Association), Spanish Ministry of Health.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to resolution	days from diagnosis until criteria for cure	1 month after admission	No
Secondary	number of children with complications.	number of children with complications.	3 months after diagnosis	No
Secondary	Number of children with complications attributable to corticoids	Hyperglycemia Signs of gastrointestinal bleeding Need of transfusion Oropharyngeal Candidiasis Allergic reaction	3 months	Yes